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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012455-20
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. Failure to follow steps/instructions. The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the non-tortuous, mildly calcified, right superficial femoral artery. A 5. 00 x 20 mm nc trek rx balloon dilatation catheter (bdc) was advanced to the lesion and inflated several times. The balloon was not entirely deflated prior to repositioning the bdc and the balloon separated from the catheter. A 7 french snare was used to retrieve the balloon. During retraction of the snare and balloon, they would not fit through the unspecified introducer sheath together. Therefore, everything was removed from the anatomy as a unit. As there was sufficient dilatation of the lesion, use of another bdc was not required. There was no reported clinically significant delay in the procedure. There was no reported adverse patient sequela. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual inspection was performed on the returned device. The reported separation was confirmed. The reported difficulty removing the balloon dilatation catheter (bdc) from the anatomy and introducer sheath could not be replicated in a testing environment due to the condition of the returned device. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. It was reported that the nc trek rx bdc was used to treat the right superficial femoral artery. It should be noted that the instructions for use (ifu) states: the nc trek rx coronary dilatation catheter is indicated for balloon dilatation in the coronary artery. It was also reported that the balloon was not entirely deflated prior to repositioning the bdc and the balloon separated from the catheter. It should be noted the ifu states: maintain negative pressure on the balloon between inflations. Withdraw the deflated dilatation catheter. The investigation determined the reported difficulty removing the bdc from the anatomy and introducer sheath and patient effects appears to be related to circumstances of the procedure; however, the reported shaft separation appears to be related to user error. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
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Brand NameNC TREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key7335749
MDR Text Key102309535
Report Number2024168-2018-01778
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number1012455-20
Device Lot Number70808G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/13/2018 Patient Sequence Number: 1
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